Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000873628
Ethics application status
Approved
Date submitted
26/06/2023
Date registered
15/08/2023
Date last updated
14/09/2023
Date data sharing statement initially provided
15/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Preliminary study of The Feelings Program for Adolescents with neurodevelopmental conditions delivered in a group clinic-based setting or parent home-based setting to explore feasibility, participant experience and the effect on social emotional domains, wellbeing and mental health concurrent with delivery of the digital version of this intervention.
Scientific title
Preliminary study of The Feelings Program for Adolescents with neurodevelopmental conditions delivered in a group clinic-based setting or parent home-based setting to explore feasibility, participant experience and the effect on social emotional domains and mental health concurrent with delivery of the digital version of this intervention.
Secondary ID [1] 309982 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 330471 0
Mild Intellectual Disability 330472 0
Autism Spectrum Disorder 330473 0
Condition category
Condition code
Neurological 327323 327323 0 0
Other neurological disorders
Mental Health 327324 327324 0 0
Learning disabilities
Mental Health 327325 327325 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Feelings Program for Adolescents (TFP-A) Digital Version was adapted from the Westmead Feelings Program (WFP) by the WFP author group for an adolescent target audience, with a diagnosis of autism spectrum disorder and co-occurring mild intellectual disability (ID).
In these two separate single arm, multi-centre, with-in subject intervention studies, in 2024, TFP-A will be delivered to adolescents with neurodevelopmental conditions (NDCs) who are enrolled in a secondary school and who have been identified as potentially benefiting from a social-emotion wellbeing program.
Based on previous studies we have conducted in over 65 NSW schools and 8 Aspect Schools, TFP-A will be delivered in either small groups in a clinic setting, or in a home-based setting with the support of a parent. Recent pilot studies of TFP-A with autistic adolescents with a range of cognitive abilities indicated that it was feasible to conduct the program in a clinic and school-based setting, and was beneficial in improving emotional competence in adolescents. However, no such program has been developed to support adolescents with a broader range of NDCs. Furthermore, in the Cerebral Palsy (CP) community, individuals, parents and peak bodies such as Cerebral Palsy Alliance, recognised a need for a similar program for adolescents with motor, communication and cognitive difficulties, such as CP. CPA will be asked to nominate staff to be training as facilitators of TFP-A to assist in the implementation of TFP-A in the clinic-setting. CPA staff will have Mental Health First Aide training and experience supporting adolescents with CP in a group environment. Co-facilitators will also be trained to provide positive behaviour support and learning support.
The CPA facilitators will be trained by authors of TFP-A to become facilitators of TFP-A. Facilitator training will include a total of 10 hours of training (via zoom) held over 4 days across 12 months. Training will include also include asynchronous learning (watching videos and reading materials. The 10 hours of synchronous learning will start with a 4 hour training session held in late 2023. In this session facilitators will be provided with an introduction to emotional development framework and TFP-A. At the end of the training facilitators will be asked to complete additional reading and familiarise themselves with TFP-A online content. Facilitators will be asked to complete an online quiz, and submit a video demonstrating a mock TFP-A (as assigned by the trainer). The quiz and video demonstration will be assessed by the trainer. To pass the initial training, staff need to achieve 80% or above on an online quiz and demonstrate competence in delivering the program through a 10min video demonstration task. If they are unsuccessful they will be provided with feedback and an opportunity to re-submit. In early 2024, before the commencement of the program, facilitators will attend an additional 2 hours training. In this session the trainer will provide a course re-fresher, and also provide feedback to the facilitators based on their video demonstrations. This session will also provide an opportunity for the facilitators to ask additional clarifying questions. The final 4 hours of training are provided to the facilitators at the end of Module 1 (2 hours) and Module 2 (2 hours). In these session the trainer will review the upcoming module, and also provide the facilitators with an opportunity to ask questions.
The manualised program provides step by step instructions on how to run the group and includes paper-based and digital-based visual supports and audio-video content. TFP-A consists of 18 sessions, each of 60 minute during, held across the year. It is expected that the program will start in Term 1, 2024 and will be completed by Term 4, 2024. A booster / review lesson will be held in Term 1, 2025. TFP-A is grouped into 3 modules covering 1) identifying and expressing emotions, 2) problem solving and perspective taking and 3) emotional regulation. A booster/review session will be held 3 months after the last clinical session and is a review and consolidation of the material already covered in the program. The booster session will be for 60 minutes. Co-facilitators will be asked to complete an implementation and attendance checklist of during the sessions as a measure of fidelity.

In the group intervention there may be between 3-6 adolescents in each TFP-A group. In the home-based program adolescents will access TFP-A with support from their parent. In TFP-A lessons, participants will engage in a lesson which includes watching videos, discussing the content of videos and completing worksheets based on their own examples. For example in lesson 1 adolescents watch a video to learn about pleasant and unpleasant feelings, they then have a class discussion on different pleasant and unpleasant feelings, followed by completing a worksheet that consolidates their learning. They are then asked to complete a worksheet based on their own example. At the end of each lesson students are given takeaway tasks based on the same worksheet. It is expected that worksheet will require 15 minutes to complete, with the support of a parent / carer in the home environment. In the clinic program all worksheets will be reviewed by the facilitators and co-facilitators to ensure that students are completing the worksheets accurately, and that students understand the material being taught. In the home-based program, parents attend parent sessions where they present their child's material for group discussion and evaluation. There are consolidation sessions at the end of each module which can provide facilitators / parents time to support additional learning. There are two versions of worksheets available for facilitators to use, a basic version and a more complex version. All adolescents will be provided with both worksheets in the first module, however based on progress and accurate completion of the worksheet, adolescents will be provided with the worksheet that best meets their learning needs in Module 2 and Module 3 (ie reduced cognitive content). Parents are provided additional support in parent sessions when making this decision.
In addition to the adolescent TFP-A, there are also separate online parent groups and online parent content. Asynchronistic online parent program will include videos, written resources and guidance to develop their skills as emotion coaches for their child. There will also be synchronistic opportunities for parents to meet with other parents in either face to face or online sessions, facilitated by TFP-A authors and CPA facilitators. The aim of the parent sessions is also to build parent capacity and confidence in supporting their child's emotional needs in a home and community context. This will include using the strategies and language taught in TFP-A. Parents will be invited to attend a face to face session (or online session if required for geographic, family or general health recommendations reasons). All parents will be provided training on the purpose of TFP-A and their role as an emotion coach. They will be introduced to the online training program and taught how to access the program and the elements covered over the year in TFP-A. Each fortnight over the course of TFP-A (Term 1, Term 2 and Term 3) parents will be asked to complete short online training modules, each one lasting for 10-30 minutes. There are 10 modules in total covering generalisation of skills in autism, emotion communication, recognising emotion body signs, recognising emotion-based behaviour, linking situations, thoughts and feelings, problem solving, perspective taking and a range of emotion regulation strategies. There will also be an additional 3 parent training session for parents in the home-based program. Content will include the role of the parent regarding parent attunement, modelling emotion regulation, mindfulness, parenting teenagers and trouble shooting delivering the program at home. Each online training module will have a learning check with 2-3 questions to assess if a parent has grasped the concepts being taught.
Parents will be asked to attend a group training session at the start of each Term to provide them with additional support and opportunity to practice new skills with the facilitator. Face to face or online sessions will be for 1 hour duration. It is asked that parents complete all the online training material and attend the 3 face to face parent sessions. Attendance records will be kept of group sessions and progress of online material will be accessed through the learning management system (LMS).
Each family will also nominate a teacher to be a school-based emotion coach. Teachers will have access to the online learning material for TFP-A including worksheets and videos of how the worksheets can be incorporated into a school setting.
Due to the small sample size, the aim of this study is to explore the feasibility of the each program, but not to compare the modes of administration to each other. Allocation to the clinic or home based program will be based on a number of factors. Firstly, in the clinic based program, adolescents will need to be willing and able to attend and participate in the group program. This will include factors such as geographic location, adequate attention and behaviour skills to engage in a group setting, and communication skills which allow for meaningful participation. The recruitment strategy includes communicating the study through the CP NSW Register. Families that first hear of the study may self select either group or home based program based on the information above (which is also included in the parent information sheet). Staff at CPA and in the professional networks of SCHN may also assist in recruitment through approaching families that they believe would be interest in the study. Staff may also assist parents in selecting group or home based option. However, through the background questionnaire and eligibility assessment, all adolescent participants will be screened for entry to the group based program. If a family is interested in the study, but the adolescent does not meet the above criteria, the family will be offered the home program.
Intervention code [1] 326403 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335195 0
Determine if the TFP-A is feasible based on composite feedback from adolescents, their parents and faciliators in both a clinic and home-based setting. Feasibility will be assessed by a researcher-developed questionnaire, with adolescent, parent and facilitator versions. Feasibility will be reported based on a combination of adolescent, parent and facilitator outcomes into a singular outcome Feasibility as reported by adolescents will be measured on a 3-point Likert Scale, where feasibility is indicated with 80% or more of respondents providing a positive score. Feasibility as reported by parents and teachers will be measured on a 5-point Likert Scale, where 80% score four or five to indicate feasibility. These component outcomes will be reported as a singular outcome.
Timepoint [1] 335195 0
Feasibility questionnaire conducted at the end of each of the 3 modules and 6 month follow up booster session with adolescents (Term 1, Term 2 and Term 3, 2024 & Term 1, 2025)
Feasibility questionnaire conducted at the end of 18 sessions (post-treatment, end of Term 4, 2024) and at 3 month follow up with parents and facilitators (end of Term 1, 2025).
Primary outcome [2] 335197 0
Evaluate changes in adolescent participants in individually developed social-emotional goals concurrent with the delivery of TFP-A.

Goal Attainment Scale (GAS) goals will be individually developed in collaboration with parents for each participant, including two goals in the home. The GAS goal is developed to create a measurable and achievable goal for each participant with defined outcomes of current skill (-1), expected improvement (+1), greater than expected improvement (+2), and decline of skill (-3) and less than expect improvement in skill (0). This scale is developed with the researcher and teacher.

Change will be described on a case-by-case basis using pre- and post-treatment scores, with a score of -1 meaning there was no change, 1 meaning there was improvement as expected, and 2 meaning there was a greater than expected improvement. Conversely a score of -2 would indicate a decline in skill area and -1 would be a smaller than expected improvement in skill. Percentage change scores will also be described.
Timepoint [2] 335197 0
Baseline - pre-treatment (By Term 1 2024)
Post-treatment (after 18th session, at the end Term 4, 2024)
Primary outcome [3] 335198 0
Evaluate changes in adolescent participants in emotions competence concurrent with the delivery of TFP-A.

Behavioural Emotional Competency Child and Adolescent Task (BECCA Task; Wong, Gardner, Ford & Dossetor, 2022) is an observation based assessment of emotional competence including use of emotion communication, emotion regulation and emotional perspective taking.

Change on sub-scales in the measure will be described on a case-by-case basis using pre- and post-treatment scores. Percentage change scores will also be described.
Timepoint [3] 335198 0
Baseline - pre-treatment (By Term 1 2024)
Post-treatment (after 18th session, at the end Term 4, 2024)
Secondary outcome [1] 423427 0
Evaluate changes in adolescent participants in parent and teacher reported emotions competence concurrent with the delivery of TFP-A and at 3 month follow up..

Emotions Development Questionnaire (EDQ; Wong, Lopes & Heriot, 2009) has been previously designed by researchers exploring earlier studies to assess change in the level of emotional competence for participants, as reported by parents and teachers.

Change on the EDQ will be described on a case-by-case basis using pre- and post-treatment, and 3 month follow up scores as a total score and also in each of the four domains (emotional expression, emotion regulation, problem solving and perspective taking). Percentage change scores will also be described.
Timepoint [1] 423427 0
Baseline - pre-treatment (By Term 1 2024)
Post-treatment (after 18th session, at the end Term 4, 2024)
3 month follow up (Term 1, 2025)
Secondary outcome [2] 423428 0
Explore any parent reported changes on the Child Behavior Checklist (CBCL) anxiety subscale to determine if there is any change after attending TFP-A.

Change will be reported in terms of change in clinical significance levels in the CBCL Anxiety subscale.

Change will be described on a case-by-case basis using pre- and post-treatment scores and 3 month follow up. Percentage change scores will also be described.
Timepoint [2] 423428 0
Baseline - pre-treatment (By Term 1 2024)
Post-treatment (after 18th session, at the end Term 4, 2024)
3 month follow up (Term 1, 2025)
Secondary outcome [3] 423429 0
Explore any teacher reported changes on the Teacher Report Form (TRF) in the anxiety subscale, to determine if there is any change after attending TFP-A.

Change will be reported in terms of change in clinical significance levels in the TRF Anxiety subscales.

Change will be described on a case-by-case basis using pre- and post-treatment scores and 3 month follow up. Percentage change scores will also be described.
Timepoint [3] 423429 0
Baseline - pre-treatment (By Term 1 2024)
Post-treatment (after 18th session, at the end Term 4, 2024)
3 month follow up (Term 1, 2025)
Secondary outcome [4] 425216 0
Explore any parent reported changes on the CBCL depression subscale to determine if there is any change after attending TFP-A.

Change will be reported in terms of change in clinical significance levels in the CBCL Depression subscale.

Change will be described on a case-by-case basis using pre- and post-treatment scores and 3 month follow up. Percentage change scores will also be described.
Timepoint [4] 425216 0
Baseline - pre-treatment (By Term 1 2024)
Post-treatment (after 18th session, at the end Term 4, 2024)
3 month follow up (Term 1, 2025)
Secondary outcome [5] 425217 0
Explore any parent reported changes on the CBCL aggression subscale to determine if there is any change after attending TFP-A.

Change will be reported in terms of change in clinical significance levels in the CBCL Aggression subscale.

Change will be described on a case-by-case basis using pre- and post-treatment scores and 3 month follow up. Percentage change scores will also be described.
Timepoint [5] 425217 0
Baseline - pre-treatment (By Term 1 2024)
Post-treatment (after 18th session, at the end Term 4, 2024)
3 month follow up (Term 1, 2025)
Secondary outcome [6] 425218 0
Explore any parent reported changes on the CBCL emotion dysregulation index (EDI) to determine if there is any change after attending TFP-A.

Change will be reported in terms of statistically significant change in mean score on EDI.

Change will be described on a case-by-case basis using pre- and post-treatment scores and 3 month follow up.
Timepoint [6] 425218 0
Baseline - pre-treatment (By Term 1 2024)
Post-treatment (after 18th session, at the end Term 4, 2024)
3 month follow up (Term 1, 2025)
Secondary outcome [7] 425220 0
Explore any teacher reported changes on the Teacher Report Form (TRF) in the depression subscale to determine if there is any change after attending TFP-A.

Change will be reported in terms of change in clinical significance levels in the TRF Depression subscale.

Change will be described on a case-by-case basis using pre- and post-treatment scores and 3 month follow up. Percentage change scores will also be described.
Timepoint [7] 425220 0
Baseline - pre-treatment (By Term 1 2024)
Post-treatment (after 18th session, at the end Term 4, 2024)
3 month follow up (Term 1, 2025)
Secondary outcome [8] 425221 0
Explore any teacher reported changes on the Teacher Report Form (TRF) in the aggression subscale to determine if there is any change after attending TFP-A.

Change will be reported in terms of change in clinical significance levels in the TRF Aggression subscale.

Change will be described on a case-by-case basis using pre- and post-treatment scores and 3 month follow up. Percentage change scores will also be described.
Timepoint [8] 425221 0
Baseline - pre-treatment (By Term 1 2024)
Post-treatment (after 18th session, at the end Term 4, 2024)
3 month follow up (Term 1, 2025)
Secondary outcome [9] 425222 0
Explore any teacher reported changes on the Teacher Report Form (TRF) on the emotion dysregulation index (EDI) to determine if there is any change after attending TFP-A.

Change will be reported in terms of statistically significant change in mean score on EDI.

Change will be described on a case-by-case basis using pre- and post-treatment scores and 3 month follow up.
Timepoint [9] 425222 0
Baseline - pre-treatment (By Term 1 2024)
Post-treatment (after 18th session, at the end Term 4, 2024)
3 month follow up (Term 1, 2025)

Eligibility
Key inclusion criteria
Adolescent participants:
• Aged 11-16 years old,
• Attending secondary school education in 2024,
• Have a diagnosis of CP and may also have co-occurring NDC (autism and/or Mild ID)
• Reported by parents and/or teachers to have social-emotional learning needs that would benefit from a targeted emotion development program.
• Be able to generate a three-word sentence on an A4-sized worksheet (with or without support, and by hand, text or scribe),
• Must speak English, and
• Must be willing and able to engage in TFP-A lesson at a time which is mutually agreed by TFP-A facilitators and to the consenting families.
Confirmation of diagnosis will be reviewed by a panel at CHW, and shall include recent medical or allied health reports submitted by parents, and through parent report assessment of current adaptive behaviour and social-emotional development and where required, a WISC-5 assessment conducted by CHW staff. Adolescent participants in the face to face clinic-based setting will attend lessons without their parent. If the co-facilitator is unable to provide the additional support required for the adolescent to attend the clinic sessions, enrolment in an alternative setting maybe considered (for example home-based program or telehealth).
Note: All parents / carers of students in the clinic-based intervention will be invited to consent for the research study, involving attending parent sessions, accessing online training and the collection of data relating to their child and TFP-A. Teachers of the participating adolescents in TFP-A sessions will also be invited to consent for the research study, involving accessing online training and the collection of data relating to their student and TFP-A.
In addition to the above, parents who are selected for the home-based program will also be required to speak English and be willing to attend additional TFP-A parent sessions in a clinical setting or via telehealth at a time which is mutually agreed by TFP-A facilitators and to the consenting families. They must also have the capacity and ability to support their child at home in learning TFP-A curriculum and practicing the new emotion-based skills at home and in community settings. Their child will not be attending TFP-A sessions as these will be completed at the family home facilitated by their parent.
The pre-treatment assessments are well-accepted, previously validated psychometric instruments that will be administered the initial assessment for diagnostic purposes and for establishing eligibility in relation to inclusion/exclusion criteria. Assessment of social-emotional difficulties, mental health and adaptive behaviour will be based on parent report using well-accepted, previously validated psychometric instruments.
Minimum age
11 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Adolescent clinic-based participants:
• Non-English speaker (speaks a language/s other than English and requires an interpreter to translate the English language) and/or is rated by parent or teacher as an inconsistent communicator with familiar people (CFCS Level IV) or seldom effective communicator even with familiar people (CFCS Level V). Clinic-based group lessons and questionnaires contain content that is difficult for people to understand if they are non-English speakers or have difficulties effectively communicating with others.
• Intellectual disability in the moderate, profound of severe range.
• Major congenital anomaly as their experience of emotional development may be less reflective of the broader CP experience.
• Significantly high levels of reported challenging behaviour or attention difficulties,
• Moderate to severe mental health issues.
As the intervention is a mental health prevention program, if current mental health difficulties are too great it may limit the ability of the participant to participate in the program or benefit from the skill building elements of the program when delivered in a group format. It is likely that the mental health difficulties will first need to be addressed by the family and mental health services.
Parent home-based participants:
• Non-English speaker (speaks a language/s other than English and requires an interpreter to translate the English language)
• Parent’s self-reporting extreme levels of mental health difficulties or stress.
• Inability to access online platform with adequate internet connection, speaker and camera. As the parent material will include an online component, internet access is required.
Parent training program contains content including psychological concepts that are difficult for people to understand if they have difficulties with the English language. If current parent mental health difficulties are too great or too entrenched, it may limit the ability of the parent to engage in the parent training or engage their child in the home-based TFP-A curriculum. As the home-based program will require the parent to be able to engage with teaching and supporting of emotion development skills, high levels of parental mental health difficulty (including depression and anxiety), or extreme levels of stress, are likely to impact the parent’s ability to engage in the program. It is likely that the mental health difficulties will first need to be addressed by the family and mental health services.

Adolescent home-based participants:
• Significantly high levels of attention or behavioural difficulties
• Moderate to severe mental health issues.
• Intellectual disability in the moderate, profound of severe range.
TFP-A delivered in a home-based setting requires participants to be comfortable working alongside their parent to learn new skills. If there are significant behaviours of concern in the home environment it is unlikely that the parent will be able to sit down with their child to work through the content of the material. As the intervention is a mental health prevention program, if current mental health difficulties of the child are too great or too entrenched it may limit the ability of the participant to participate in the program or benefit from the skill building elements of the program when delivered in a group format. It is likely that the mental health difficulties will first need to be addressed by the family and mental health services.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Implementation study. Due to the different settings (group clinic-based setting or home-based setting) different groups of participants will receive different modes of delivery of TFP-A, during the same time span of the study.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/11/2023
Actual
Date of last participant enrolment
Anticipated
15/03/2024
Actual
Date of last data collection
Anticipated
11/04/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24986 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 40641 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 314138 0
Hospital
Name [1] 314138 0
The Children's Hospital at Westmead
Country [1] 314138 0
Australia
Primary sponsor type
Hospital
Name
The Children's Hospital at Westmead
Address
Locked Bag 4001, Westmead, NSW, 2145
Country
Australia
Secondary sponsor category [1] 316078 0
Charities/Societies/Foundations
Name [1] 316078 0
Cerebral Palsy Alliance
Address [1] 316078 0
187 Allambie Rd, Allambie Heights, NSW, 2100
Country [1] 316078 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313274 0
Sydney Children's Hospitals Network HREC
Ethics committee address [1] 313274 0
Locked Bag 4001, Westmead, NSW 2145
Ethics committee country [1] 313274 0
Australia
Date submitted for ethics approval [1] 313274 0
30/06/2023
Approval date [1] 313274 0
10/08/2023
Ethics approval number [1] 313274 0
2023/ETH01391

Summary
Brief summary
In Australia, approximately one in ten children meet criteria for a neurodevelopmental condition. Neurodevelopmental conditions (NDCs) include Autism, Cerebral Palsy (CP), intellectual and learning disabilities. Impairments in cognition, communication, perception, and behaviour also frequently accompany both autistic individuals and those with CP. It is also common for children to have more than one NDCs. For example, of the one in 36 children that are diagnosed on the autism spectrum 88% will have additional co-occurring disability, commonly another NDC. Autism is also more prevalent in children with CP than it is in population studies, with studies estimating between 2% to 30% of children with CP also meet criteria for autism.
Rates of mental health problems in adolescents with NDCs have also started to be explored. While 14% of all young people in Australia will experience a mental health condition, this compares to approximately 70% of autistic young people, over 40%-46% of young people with CP. However, unlike NDCs, most mental health conditions have the potential to be preventable, reversable or improved.
Despite the additional support needs, interventions aimed at promoting wellbeing and mental health in adolescents with NDCs are extremely limited. The Westmead Feelings Program (WFP) was the first therapy program for children with NDCs aimed at improving emotional development skills with a focus on preventing mental illness. The Feelings Program for Adolescents (TFP-A) is the first program targeted at autistic adolescents with co-occurring mild ID and has also included adolescents with more significant communication and learning support needs.
Previous studies of WFP and TFP-A report the programs to be feasible and enjoyable, and demonstrate improvements in emotional competence, and an increase in confidence for the parent and teacher in supporting social-emotional development.
The present study involves The Feelings Program for Adolescents being delivered in a clinic-based or home-based setting, facilitated by CPA staff and parents. The primary purpose of the study is to explore the feasibility of TFP-A delivered in clinic and home-based settings, and efficacy of TFP-A in impacting emotional competence, social skills, problem behaviours, wellbeing and mental health of adolescents with NDCs. It is hypothesised that TFP-A will be found to be feasible in both settings, and will correlate with improvements in outcome measures including emotional competence, wellbeing and mental health in adolescents with NDCs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127566 0
Mrs Anita Gardner
Address 127566 0
Department of Psychological Medicine
The Children's Hospital at Westmead
Locked Bag 4001
Westmead, NSW, 2145
Country 127566 0
Australia
Phone 127566 0
+61298452005
Fax 127566 0
Email 127566 0
anita.gardner@health.nsw.gov.au
Contact person for public queries
Name 127567 0
Mrs Anita Gardner
Address 127567 0
Department of Psychological Medicine
The Children's Hospital at Westmead
Locked Bag 4001
Westmead, NSW, 2145
Country 127567 0
Australia
Phone 127567 0
+61298452005
Fax 127567 0
Email 127567 0
anita.gardner@health.nsw.gov.au
Contact person for scientific queries
Name 127568 0
Mrs Anita Gardner
Address 127568 0
Department of Psychological Medicine
The Children's Hospital at Westmead
Locked Bag 4001
Westmead, NSW, 2145
Country 127568 0
Australia
Phone 127568 0
+61298452005
Fax 127568 0
Email 127568 0
anita.gardner@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Preliminary data will be available at the end of the intervention study (August 2025). Participants have also been asked to provide consent for de-identified data to be stored indefinitely in a secure online server at The Children's Hospital at Westmead. There is no end date for the availability of that data, however all other research data will be stored as per the Hospital policy.
Available to whom?
De-identified data may be shared with universities or research partners where there is a research agreement signed and endorsed by The Sydney Children's Hospitals Network Governance and the Department of Psychological Medicine.
Available for what types of analyses?
The data will be available for any analysis that aims to achieve the aims in the approved proposal.
How or where can data be obtained?
Anyone wishing to obtain data will need to contact the research investigators at the Department of Psychological Medicine, The Children's Hospital at Westmead. To do so, they must email the principal investigator, Anita Gardner at Anita.Gardner@health.nsw.gov.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19539Study protocolGardner, Wong & Baldwin (2023). An Explorative Study of Digital Mental Health Programs for Adolescents with Neurodevelopmental Conditions . (Study Protocol). The Children's Hospital at Westmead; Sydney, Australia. anita.gardner@health.nsw.gov.au On request by email.
19540Informed consent form  anita.gardner@health.nsw.gov.au On request by email.
19541Clinical study report  anita.gardner@health.nsw.gov.au On request by email (once study is concluded).
19542Ethical approval  anita.gardner@health.nsw.gov.au On request by email (once approved)



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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